Development of the FibWave, an improved clot waveform analysis for the assessment of hemostasis

PhD thesis defended by Jonathan EVRARD (Prof. Jonathan DOUXFILS) - 11/04/2023

Prof. Jonathan DOUXFILS, UNamur, Pharmacy department

  • Fabian DEMEURE, Université Catholique de Louvain
  • Jean-Michel DOGNE, Université de Namur, Dpt Pharmacie
  • Jonathan DOUXFILS, Promoteur, Université de Namur, Dpt Pharmacie
  • Aurélien LEBRETON, CHU Clermont Ferrand, France
  • Bernard MASEREEL, Université de Namur, Dpt Pharmacie
  • François MULLIER, Université de Namur, Dpt Pharmacie
  • Hugo TEN CATE, Université de Maastricht
  • Peter VERHAMME, KU Leuven

Thromboembolic and hemorrhagic disorders are a global public health problem. Over the last 50 years, research has focused on developing strategies to reduce the mortality and morbidity associated with these diseases. Many studies have been conducted on the assessment of thromboembolic and hemorrhagic risks and the adaptation of patient treatment. In this context, the accessibility of clinical tests is essential to improve the prevention of these disorders.

Currently, many assays, reagents and coagulation analyzers are on the market. Although reagents and assays are readily available, they display various sensitivities. The sensitivity of the reagents depends on the composition of the reagent including the type of activator, the origin and composition of the phospholipids. For coagulation tests, turbidimetry or mechanical detection, viscoelastometry, resonance, visual or fluorometric monitoring are part of the methods available in the laboratory.

The present PhD thesis describes different global hemostasis assays (clot waveform analysis (CWA), global hemostasis potential (OHP), thrombin generation assay (TGA), viscoelastic methods (TEG/ROTEM) and their potential in clinical applications. Based on some coagulation assays, we aimed to develop a new coagulation method evaluating the fibrin formation kinetics. The method, named the FibWave, allows assessing the global coagulation process by measuring turbidity changes during the fibrin clot formation. An idea of the clot waveform can be depicted in real time and, in addition to obtaining a clotting time, additional coagulation parameters can be extracted.

A description of the FibWave and a proof of concept in procoagulant and anticoagulant states will be provided and the perspectives according to the new in vitro diagnostic medical devices regulation (IVDR) of FibWave will be presented.